Services -- Clinical Research

Clinical Trial and Other Study-Related Agreements

   ♦ CROs
      • Sponsor Master Services Agreements
      • Clinical trials management
   ♦ Investigators
   ♦ Contract Labs
      • Preclinical testing
   ♦ IRBs
   ♦ Active Pharmaceutical Ingredient (API) supply sourcing
   ♦ Component sourcing deals
   ♦ Consultants 

   ♦ Clinical data ownership


Good Clinical Practice (“GCP”) -- Compliance & Training

   ♦ SOPs –
      • drafting
      • review
   ♦ Compliance
      • audits
      • training
   ♦ HIPAA and privacy considerations
      • implementing procedures in clinical trials
      • consents

   ♦ Clinical Trial Registry & Results Database Duties
   ♦ State regulatory requirements 

  

Research Document Reviews

   ♦ Protocols

   ♦ Informed Consent Documents


Financial Disclosure Requirements – Compliance and Strategies

   ♦ Federal:  FDA & HHS
   ♦ Institutional (e.g., university, hospital)
   ♦ Clinical trial design to minimize conflicts 


State Law Issues

   ♦ Privacy

   ♦ Assent/Consent Issues

   ♦ Medical Records

   ♦ Legally Authorized Representatives (LARs)

For presentations and articles on Clinical Research, ...